FDA UDI
In Commercial Distribution
🇺🇸 United States
ATOZ-Tooth Connection Arms
DI: 08800197900044
·
Model: MK-Wire arm-1240
·
MK Meditech Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ATOZ-Tooth Connection Arms
- Primary DI
- 08800197900044
- Version / Model
- MK-Wire arm-1240
- Company Name
- MK Meditech Inc.
- Labeler DUNS
- 695009476
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-22
- Public Version
- 2
- Public Version Date
- 2023-10-16
- Public Version Status
- Update
- Public Device Record Key
- cdb65944-1dd3-4a61-9b86-63166e9e584b
Device Description
PRODUCT SUMMARY This is a bendable stainless steel wire which can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement. TRADE NAME ATOZ Wire arm * 4EA MODEL NAME MK Wire arm-1240 INDICATION FOR USE This can be connected to the ATOZ expander and expand premolars and molars simultaneously or provide anchor point for various teeth movement with bending the wire arm various shape according to the treatment plan. PRODUCT MATERIAL 316L Stainless Steel CONSIST OF: MK-Wire arm-1240*4ea
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZC | Wire, Orthodontic | Dental | 872.5410 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41397 | Orthodontic archwire | A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800197900044 | GS1 |